Validation Engineer
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
Validation Engineer voor CQV-activiteiten in een GMP-gereguleerde farmaceutische omgeving in Hoofddorp.
- Locatie
- Hoofddorp
- Werkvorm
- op locatie
- Uren
- 40 uur per week
- Contractvorm
- detachering
- Sluitingsdatum
- Eerste waarneming
- Opdrachtgever
- Global leader in advanced cell therapy
Signalen van een warme stoel: Open posting voor een niche GMP/CD/validatierol bij een prominente (niet met naam genoemde) celtherapieleider, met specialistische en verplichte eisen, maar zonder tarief, duur of sluitingsdatum en dus beperkt onderscheidend.
Dit is een inschatting op tekstkenmerken, geen bewijs. Zo werkt de warme stoel check.
Eisen
- MBO level 4 with at least 4 years of relevant experience, or HBO with at least 3 years of experience
- Proven GMP experience within the pharmaceutical or related industries
- Prior validation experience in a regulated environment
Omschrijving
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety. As a Validation Engineer you will be responsible for executing commissioning, qualification, and validation activities for equipment, utilities, facilities, and computerized systems in a GMP-regulated pharmaceutical environment. The role supports the full validation lifecycle, including protocol development and execution (IQ/OQ/PQ), deviation management, CSV documentation, and coordination with Quality, Engineering, and external contractors to ensure compliance and inspection readiness. Responsibilities include performing routine commissioning, qualification, and validation (CQV) tasks, including temperature mapping and related validation activities; developing and executing validation protocols for equipment, utilities, facilities, and computerized systems, including IQ, OQ, PQ, and validation plans; investigating deviations and exceptional conditions, implementing corrective and preventive actions (CAPAs) to resolve issues; assisting with calibration and certification of validation instruments to maintain accuracy and compliance; reviewing and approving technical documentation such as protocols, summary reports, test records, and validation SOPs; creating and maintaining Computerized System Validation (CSV) documents like risk assessments, validation plans, user acceptance tests (UATs), and final reports; and collaborating with Quality Engineering to establish and update validation strategies and standard procedures. Requirements: MBO level 4 with at least 4 years of relevant experience, or HBO with at least 3 years of experience; proven GMP experience within the pharmaceutical or related industries; prior validation experience in a regulated environment.
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